Preoperative Vegetative StressNCT06093750
Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability
An observational study of Preoperative Vegetative Stress, run by Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA at 1 site in Austria.
Trial summary
The purpose of the study is to investigate whether there is a correlation between the vegetative stress evaluated by the State-Trait-Anxiety-Inventory (STAI-Test) and the measurement of heart rate variability (HRV). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Preoperative Vegetative Stress
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- 5 Jun 2023to 2 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subjects are recruited after the anesthesia interview with the anesthesiologist. anesthesiologist. Subjects with elective surgery associated with a low risk of bleeding will be included. This includes procedures such as knee arthroplasties, cruciate ligamentoplasties, or metal removals.
Who may be able to join
- Subjects between 18 and 65 years
- Elective surgery with a low risk of bleeding
- American Society of Anesthesiologists (ASA) classification 1-2
- metabolic equivalent of task (MET) > 4
Who cannot join
- Pre-existing cardiac conditions such as heart failure, arterial hypertension,
- diabetes
- any central nervous system diseases
- cardiac pacemaker
- renal and hepatic insufficiency
- regional or peridural anesthesia
- Pregnancy, lactation
- Drugs that directly influence the autonomic nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability: An Observational Cohort and Pilot Study
The purpose of the study is to investigate whether there is a correlation between the vegetative stress evaluated by the State-Trait-Anxiety-Inventory (STAI-Test) and the measurement of heart rate variability (HRV). A subgroup analysis will also be performed to determine whether premedication contributes to a lower STAI score and/or heart rate variability. The primary outcome will be the parameter of frequency-based analysis Low Frequency (LF) and High Frequency (HF), and the STAI score. Secondary outcomes are the parameters Low Frequency/High Frequency-ratio (LF/HF-ratio), Standard deviation of normal-to-normal (NN) intervals (SDNN), Root Mean Square of successive differences" (RMSSD) and mean heart rate, age, gender, if they are smokers and if they work in shifts.
- Conditions
- Preoperative Vegetative Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
State and Trait Anxiety Inventory (STAI-score)
STAI: State-Trait-Anxiety-Inventory-Score This test consists of 40 items and assesses the current state of anxiety in relation to the current situation in which the patient is to the current situation in which the patient finds herself (State Anxiety) and the general anxiety state existing state of anxiety, which represents a part of her personality (Trait Anxiety). A score of 20-80 could be achieved, with higher scores correlating with correlated with higher anxiety levels. Accordingly, scores of 20-39, 40-59, and 60-80 would indicate low, moderate, and high anxiety.
Measured: First questionnaire is given 40 minutes before transfer to the holding area and the second questionnaire postoperative in the recovery ward directly before transfer back to ward
The measurement method of heart rate variability (especially the parameter of the frequency domain Low Frequency and High Frequency
Low frequency power (LF):
Power density spectrum in the frequency range from 0.04-0.15 Hz
High frequency power (HF):
Power density spectrum in the frequency range from 0.15 to 0.40 Hz
Measured: One measurement (3-6 hours), start of measurement together with the first STAI questionnaire (40 min before transfer to the holding area), end of measurement after the second STAI questionnaire is done.
Secondary outcomes (2)
Heart rate variability ("Standard deviation of normal-to-normal (NN) intervals" (SDNN) and "Root Mean Square of successive differences" (RMSSD) of the time domain and "LF/HF-ratio" from the frequency domain) as well as mean heart rate
Standard deviation of NN-intervals (SDNN):
intervals in the measuring range; NN-intervals refer to the intervals between normal R-peaks in an electrocardiogram
Root Mean Square of successive differences (RMSSD)
Low Frequency/High Frequency-ratio (LF/HF ratio):
Quotient of the spectrum in LF and the spectrum in HF, No clear assignment, Ratio or Coefficient or Ratio between LF-and HF Band power
Measured: HRV-parameters and mean heart rate were obtained in the same time frame as outcome 2.
Age, gender, if they are smokers and if they work in shifts
Age: 18-65
Gender: male, female
smoker: no, (never; nonsmoker > 1 year), yes (< 5/d; 6-15/d; >15/d)
working in shifts: yes, no
Measured: Outcomes will be collected following the routine anaesthesia interview with the anaesthesiologist as part of the recruitment process.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start5 Jun 2023
- Primary completion30 Sep 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative Vegetative StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
- Sponsor type
- Other government
- Collaborators
- UKH Salzburg, University of Ulm, Institute for Salutology
- Responsible party
- Sponsor
- Investigators
- Gerhard Fritsch, PD. Dr., Principal investigator, Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093750
- Sponsor's protocol ID
- Version 1.2
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between State-Trait-Anxiety-Inventory and Heart Rate Variability: An Observational Cohort and Pilot Study
- ClinicalTrials.gov ID
- NCT06093750
- Acronym / sponsor ID
- Version 1.2
- Conditions
- Preoperative Vegetative Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVAOther government
- Collaborators
- UKH Salzburg, University of Ulm, Institute for Salutology
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate whether there is a correlation between the vegetative stress evaluated by the State-Trait-Anxiety-Inventory (STAI-Test) and the measurement of heart rate variability (HRV). A subgroup analysis will also be performed to determine whether premedication contributes to a lower STAI score and/or heart rate variability. The primary outcome will be the parameter of frequency-based analysis Low Frequency (LF) and High Frequency (HF), and the STAI score. Secondary outcomes are the parameters Low Frequency/High Frequency-ratio (LF/HF-ratio), Standard deviation of normal-to-normal (NN) intervals (SDNN), Root Mean Square of successive differences" (RMSSD) and mean heart rate, age, gender, if they are smokers and if they work in shifts.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects are recruited after the anesthesia interview with the anesthesiologist. anesthesiologist. Subjects with elective surgery associated with a low risk of bleeding will be included. This includes procedures such as knee arthroplasties, cruciate ligamentoplasties, or metal removals.
Key inclusion criteria (4 listed)
- Subjects between 18 and 65 years
- Elective surgery with a low risk of bleeding
- American Society of Anesthesiologists (ASA) classification 1-2
- metabolic equivalent of task (MET) > 4
Key exclusion criteria (8 listed)
- Pre-existing cardiac conditions such as heart failure, arterial hypertension,
- diabetes
- any central nervous system diseases
- cardiac pacemaker
- renal and hepatic insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
State and Trait Anxiety Inventory (STAI-score)
Time frame: First questionnaire is given 40 minutes before transfer to the holding area and the second questionnaire postoperative in the recovery ward directly before transfer back to ward
STAI: State-Trait-Anxiety-Inventory-Score This test consists of 40 items and assesses the current state of anxiety in relation to the current situation in which the patient is to the current situation in which the patient finds herself (State Anxiety) and the general anxiety state existing state of anxiety, which represents a part of her personality (Trait Anxiety). A score of 20-80 could be achieved, with higher scores correlating with correlated with higher anxiety levels. Accordingly, scores of 20-39, 40-59, and 60-80 would indicate low, moderate, and high anxiety.
The measurement method of heart rate variability (especially the parameter of the frequency domain Low Frequency and High Frequency
Time frame: One measurement (3-6 hours), start of measurement together with the first STAI questionnaire (40 min before transfer to the holding area), end of measurement after the second STAI questionnaire is done.
Low frequency power (LF): Power density spectrum in the frequency range from 0.04-0.15 Hz High frequency power (HF): Power density spectrum in the frequency range from 0.15 to 0.40 Hz
2 secondary outcomes
Heart rate variability ("Standard deviation of normal-to-normal (NN) intervals" (SDNN) and "Root Mean Square of successive differences" (RMSSD) of the time domain and "LF/HF-ratio" from the frequency domain) as well as mean heart rate
Time frame: HRV-parameters and mean heart rate were obtained in the same time frame as outcome 2.
Age, gender, if they are smokers and if they work in shifts
Time frame: Outcomes will be collected following the routine anaesthesia interview with the anaesthesiologist as part of the recruitment process.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Fritsch, PD. Dr. principal investigator
Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preoperative Vegetative Stress, run by Ludwig Boltzmann Institute for Traumatology - The research center in cooperation with AUVA at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State and Trait Anxiety Inventory (STAI-score) (time frame: First questionnaire is given 40 minutes before transfer to the holding area and the second questionnaire postoperative in the recovery ward directly before transfer back to ward). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.